CAPA Specialist
Core
Facilitate and execute the Corrective and Preventive Action (CAPA) process to ensure compliance, quality, and timeliness of records in a medical device context.
Role type
Quality Assurance CAPA Specialist
Builds
CAPA records, quality reports, and continuous improvement initiatives
Domain
Medical device manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA process execution, root cause analysis, FDA regulations knowledge, GMP compliance, ISO 13485 knowledge, data analysis, report writing, project management, cross-functional collaboration, audit support
Preferred skills
Six Sigma training, ASQ CQT/CQE/CQA certification, medical device experience, Masters degree
Technologies
Electronic Quality Management Systems, statistical analysis tools
Responsibilities
Investigate quality issues and gather data, lead CAPA projects and meetings, process CAPA requests and assign owners, assist with metrics and reporting, support CAPA training programs, provide subject matter expertise during audits and inspections, lead continuous improvement initiatives
Seniority
Mid-level individual contributor